Cleared Traditional

K041272 - DYRACT CEM PLUS CEMENT

K041272 is an FDA 510(k) clearance for DYRACT CEM PLUS CEMENT, manufactured by Dentsply Intl.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K041272 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
159d
Days
Class 2
Risk

K041272 is an FDA 510(k) clearance for the DYRACT CEM PLUS CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on October 18, 2004 after a review of 159 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dentsply Intl. devices

FDA 510(k) Submission Details - K041272

510(k) Number K041272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2004
Decision Date October 18, 2004
Days to Decision 159 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 127d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EMA Cement, Dental

All 433
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K041272.
SYSTEMP.CEM
K042847 · Ivoclar Vivadent, Inc. · Dec 2004
RIVA SILVER
K042452 · Southern Dental Industries, Inc. · Dec 2004
IONOFIL PLUS AC
K042669 · Voco GmbH · Oct 2004
RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT
K042215 · Premier Dental Products Co. · Sep 2004
MAXCEM
K041474 · Sybron Dental Specialties, Inc. · Jul 2004
CALIBRA CEMENT
K040906 · Dentsply Intl. · Jun 2004